MAALOX PLUS*ORAL SUSP 4+3.5+0.5%

MAALOX PLUS 4% + 3.5% + 0.5% oral suspension lemon flavour
Magnesium hydroxide + Aluminum hydroxide + Simethicone

What it is and what it is used for
This medicine contains the following active ingredients: magnesium hydroxide and aluminum hydroxide which act as antacids in the stomach, and simethicone which absorbs intestinal gases.

MAALOX PLUS is a medicine used for the treatment of:
• symptoms of excess stomach acid (hyperacidity) such as heartburn and pain, also in cases of inflammation of the esophagus (esophagitis) and hyperacidity when accompanied by digestive problems (dyspepsia);
• symptoms of excess gas in the stomach and intestines when associated with hyperacidity.

Consult your doctor if you do not feel better or if you feel worse.

What you need to know before taking the medicine
Do not use MAALOX PLUS
- if you are allergic to the active ingredients or any of the other ingredients of this medicine (listed in section 6); signs of an allergic reaction are skin rashes, swelling of the lips, tongue, face and throat, breathing problems;
- if you suffer from porphyria (a rare inherited disorder of blood metabolism);
- if you have severe kidney problems;
- if your body is severely wasted (cachexia);
- in children and adolescents under 18 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking MAALOX PLUS:
- if you have intestinal problems or constipation, if you have non-severe kidney problems or are elderly because this medicine could worsen intestinal problems;
- if you are following a low-phosphorus diet, if you have low blood phosphate levels (hypophosphatemia) or in case of long-term treatment. This medicine reduces blood phosphate levels and can cause bone problems (see “Possible side effects”).

If you are taking this medicine at a high dosage or if you are prone to diarrhea, be careful because this medicine can cause diarrhea (see section 4 “Possible side effects”).

Children and adolescents
This medicine should not be used in children and adolescents under 18 years of age.
In young children, the use of magnesium hydroxide can cause hypermagnesemia, particularly if they have kidney damage or dehydration.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking MAALOX PLUS and contact your doctor or the nearest hospital immediately if you experience: difficulty breathing or swallowing, swelling of the face, hands and feet, eyes, lips and/or tongue, skin rashes, itching, hives and dizziness; these can be symptoms of severe allergic reactions (angioedema and anaphylactic reaction).

The following side effects may occur with the use of this medicine:
Uncommon (may affect up to 1 in 100 people):
- constipation or diarrhea (see section 2 “Warnings and precautions”).
Very rare (may affect up to 1 in 10,000 people):
- hypermagnesemia, including observations after prolonged administration to patients with kidney damage.
Frequency unknown (frequency cannot be estimated from the available data)
- excessive reaction of the body to foreign substances (hypersensitivity reaction), more or less itchy skin rash characterized by the appearance of swellings on the skin (hives), itching;
- altered levels of aluminum and phosphate in the blood which can cause bone problems (see section 2 “Warnings and precautions”);
- abdominal pain.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.